On Monday, 12 January 2026 a division bench of the Delhi High Court comprised of Justice Hari Shankar and Justice Om Prakash Shukla approved the sale of a biosmilar version of nivolumab, a cancer drug marketed by the firm Zydus under the name, ZRC 3276. In 2019, the World Health Organization (WHO) placed nivolumab on its Essential Medicines List . Nivolumab is a checkpoint inhibitor used to treat a suite of cancers including melanoma, lung cancer, kidney cancer, and lymphoma. The division bench overruled an earlier order issued by Justice Mini Pushkarna on 18 July 2025 which enjoined Zydus from releasing its biosimilar, ZRC 3276, on the grounds that it infringed on Bristol-Myers Squibb’s patent.
Underpinning the division bench’s ruling is the principle of the public interest referenced six times in the court order. A second pillar of the judgment reinforces the requirement for product-to-claim mapping with references to the “High Court of Delhi Rules Governing Patent Suits” and “DHC Patent Suit Rules”.
Paragraph 1 of the decision notes:
“1. This appeal throws up issues, for consideration, which are of fundamental importance, not merely as legal principles relating to the patent regime, but also vitally of public interest.”
Paragraph 2 of the decision refers to the July 2025 order by Mini Pushkarna noting that Zydus’s biosimilar, ZRC 3276 would be “70% cheaper” than the BMS product.
2. The impugned order restrain[ed] the appellant from manufacturing or releasing, in the market, its product ZRC 3276, which is an anti-cancer drug and is essential for treatment of a wide variety of lifethreating carcinomas, on the premise that the product infringes the respondent’s patent. According to the appellant, treatment, using the appellant’s product, would be 70% cheaper than treatment using the respondent’s patented drug 5C4.
Paragraph 3 of the order reinforces the Supreme Court’s guidance on public interest considerations when considering cases involving injunctive relief. The counterpoint is paragraph 4 which notes that
“[i]ntellectual property rights are entitled to protection.”
3. The Supreme Court has, in its decisions in Ramnik Lal Bhutta v. State of Maharashtra1 and Raunaq International v. I.V.R. Construction Ltd, held that, while considering pleas for injunction or stay, public interest is also a consideration to be borne in mind, apart from the classical troika of a prima facie case, balance of convenience and irreparable loss.
4. That said, we have no doubt about the fact that the mere fact that the injuncted product is a life saving drug is no absolute armour against injunction. Products which infringe patents of others cannot be permitted to circulate in the market. Intellectual property rights are entitled to protection.
Paragraph 20 of the ruling highlights the Delhi High Court’s approach on “keeping in mind the pre-eminent consideration of public interest”.
20. Rather, given the fact that the product is a life saving drug needed for cancer therapy, and keeping in mind the pre-eminent consideration of public interest, we are of the opinion that the interests of justice would adequately have been subserved if the appellant were to be directed to maintain and file, with this Court, periodical accounts of the amounts earned through sale of the appellant’s product, so as to secure the respondent in the event of its succeeding in the suit.
Following on from these public interest considerations, the Delhi High Court reasoned that the nivolomab “should be made available to the public for the next four months” given that BMS’s patent nivolumab expires on 2 May 2026 in India.
21. Besides, the suit patent expires on 2 May 2026. Thereafter, there can be no embargo on anyone marketing the patented drug. The only issue is, therefore, whether the appellant’s product should be made available to the public for the next four months. Given the nature of the product, and applying the principle of balance of convenience, too, the interests of justice would require the appellant to be bound down to maintain accounts of the realizations from the sale of its product till the expiry of the suit patent, rather than depriving the ailing public of access to the product.
In relation to the BMS suit against Zydus, the Division Bench of the Delhi High Court remarked on the notable absence of product-to-claim mapping.
Paragraphs 5 through 9 of the decision are reproduced below.
5. This case, however, is peculiar, as there is admittedly no mapping of the appellant’s product ZRC 3276 onto the claims in the respondent’s suit patent at any stage. Injunction has, therefore, been granted without any product-to-claim mapping.
6. The impugned order seeks to justify this course of action on the ground that the suit is a quia timet action, instituted in anticipation of future infringement and that, therefore, as the appellant’s product is not commercially available, no product-to-claim mapping is possible.
7. Rule 3(A)(ix) of the High Court of Delhi Rules Governing Patent Suits, 2022 specifically requires product-to-claim mapping as one of the necessary ingredients of a patent infringement suit. However, the impugned judgment holds that the words “to the extent possible”, in Rule 3A may, in a quia timet action, justify doing away with the requirement of product-to-claim mapping altogether.
8. This is of vital importance, as Section 48 of the Patents Act, 1970 confers, on the holder of a registered patent, the exclusive right to prevent third parties from using, offering, selling or importing that product in India, without consent of the patentee. The issue of whether, in the absence of any mapping of the defendant’s product to the plaintiff’s granted claim in the suit patent, the defendant’s product can be said to be that product, therefore, requires serious consideration. Especially so as the product is a life-saving drug needed for cancer therapy.
9. The learned Single Judge holds that, even in the absence of product-to-claim mapping, the fact that the appellant’s product is in fact the product claimed in the suit patent stands prima facie established through other material.
The division bench of the Delhi High Court contested Justice Pushkarna’s (referred to below as the “learned Single Judge”) product-to-product mapping; paragraphs 15 through 19 are reproduced below.
15.1 In fact, submitted the appellant, the respondent’s 5C4 product itself did not conform to the granted claim in the suit patent, as it, too, had a ‘p’ binding factor of much less than 0.05. The learned Single Judge has held that, as ZRC 3276 and 5C4 were both revealed, on testing, to bind comparably to CD 28 proteins other than PD-1, ZRC 3276 mapped onto the suit patent.
15.2 This is, to our mind, fundamentally flawed, as it would envisage a product-to-product mapping, whereas patent infringement is to be assessed on the basis of a product-to-claim mapping. In fact, the position would be that neither ZRC 3276, nor 5C4, would actually map onto the granted claim in the suit patent.
16. On the second aspect of the claim in the suit patent, of aminoacid sequencing, the learned Single Judge observes that (i) the appellant had sought exemption from detailed drug control research on the ground that ZRC 3276 is a biosimilar of Nivolumab which was, therefore, the “reference biologic” of ZRC 3276, (ii) 5C4, which was the claimed antibody in the suit patent, had the same amino acid sequencing as in Nivolumab and (iii) biosimilars had necessarily to have the same amino acid sequencing. Once, therefore, as its biosimilar, ZRC 3276 had the same amino acid sequencing as Nivolumab, and 5C4 also had the same amino acid sequencing as Nivolumab, the corollary would be that ZRC 3276 and 5C4 have the same amino acid sequences. If a equals b, and c equals b, holds the learned Single Judge, a must necessarily equal c.
17. It is in premise (iii) of this reasoning that, to our mind, the learned Single Judge has erred. There is nothing, in the impugned judgment, to indicate, as an inflexible principle, that biosimilars have the same amino acid sequencing.
18. Apart from this “biosimilar analysis”, there is nothing, in the impugned judgment, to sustain the prima facie finding that ZRC 3276 has the same amino acid sequences as 5C4. Indeed, there could be none, as there has never been, at any stage, mapping of the appellant’s ZRC 3276 product to the respondent’s granted claim in the suit patent.
19. To our mind, while precise product-to-claim mapping, as envisaged by Rule 3(A)(ix) of the DHC Patent Suit Rules may, in a given case, suffice to establish a prima facie case of infringement, the collateral material, on the basis of which the learned Single Judge has proceeded, in the absence of any product-to-claim mapping, raise, at the best, issues which are highly arguable, and would require expert evidence. We are, therefore, unable to satisfy ourselves that, on this material, the learned Single Judge was justified in entirely injuncting the appellant from releasing its product in the market.
In the absence of product-to-claim mapping, the division bench of the Delhi High Court provided the following justification for overturning Justice Pushkarna’s ruling enjoining Zydus from marketing its biosimilar version of nivolumab.
26.5.1 In a case as involved as this, we are of the opinion that it would be erroneous to injunct the appellant from releasing its product in the market without any product-to-claim mapping with the suit patent. While product-to-claim mapping may not be a cast-in-iron imperative in every case, in its absence, there must be overwhelming circumstantial material to indicate that the defendant’s product maps onto the suit patent. There must be, in a manner of speaking, a continuous and unbroken chain of circumstances to that effect. There is no room for assumption and presumption.
26.5.3 Courts have to be acutely conscious of their duties in such matters. The tightrope is shaky, and walking it is not always an enviable enterprise. Our oath of office, however, obligates us todo so and, while doing so, we have to bear in mind our duty to the teeming citizenry of this country who may be in dire need of the therapy, the release of which a plaintiff seeks to injunct.26.5.2 This would be additionally so in a case such as the present, when the injunction that is sought is against the release, in the market, of a life giving therapeutic preparation, especiallywhere it is to treat an ailment such as cancer. Courts owe a debt to society. Public interest is, as held in Ramnik Lal Bhutta and Raunaq International, also a pre-eminent consideration while deciding whether to grant, or not to grant, an absolute interlocutory injunction.
26.5.4 There is, at the same time, also a pre-eminent element of public interest in ensuring protection of valuable patents, which not be forgotten. If Courts are to swing to the other extreme, and openly allow circulation, in the market, of drugs which infringe valuable pharmaceutical patents, the incentive to invent would be altogether lost, which might result in ebbing the stream at the source. There would be no incentive to expend valuable time, energy and often cripplingly huge financial resources in inventing a new and more efficacious drug, if one is not ensured of patent protection as available in law.
26.5.6 Where, however, a clear cut case of patent infringement, within the meaning of Section 48, is made out, on the basis of product-to-claim mapping, and there is no credible challenge made out to the validity of the asserted suit patent, the Court has to protect the patentee from infringement. On that, to our mind, there can be no compromise.
26.5.7 Where, however, no product-to-claim mapping has been attempted, and the Court is relying on other collateral material, that material, to our mind, has to be so conclusive, even at the prima facie stage, as to indicate that the defendant’s product is that product of which the plaintiff holds the patent, before its dissemination to the public can be restrained.
Paragraph 26.5.8 of the decision stressed that “where the product in question is a life-saving drug, the Court has to err in favour of public interest, and ensure securing of the plaintiff’s interest by alternate methods, short of making the drug unavailable to the public during the entire period for which the suit would remain pending. Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives”
26.5.8 Where the issue is triable, or involves complicated technical issues which would appropriately need a trial, then, in our opinion, where the product in question is a life-saving drug, the Court has to err in favour of public interest, and ensure securing of the plaintiff’s interest by alternate methods, short of making the drug unavailable to the public during the entire period for which the suit would remain pending. Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives, and it is therefore, only where the Court is in possession of irrefutable material to indicate that a patented product is being released in the market without permission of the patentee, in breach of Section 48, that an injunction can issue.
26.5.9 Tested on this crucible, we are of the opinion that, in the present case, the issues which have persuaded the learned Single Judge to restrain the appellant from manufacturing or releasing ZRC 3276 in the market do not make out such a clear prima facie case as would justify the injunction. The issues are extremely technical, and would clearly require expert technical evidence to be led before even a prima facie view can be taken.
26.5.10 We are additionally persuaded in the view we take as the suit patent, in any event, expires on 2 May 2026, after which the respondent cannot, in any case, injunct the appellant from releasing its product in the market.
In conclusion, the the Division Bench of the Delhi High Court denied injunctive relief to BMS, but provided a pathway to compensatory liability.
27. In these circumstances, we are of the opinion that the interests of justice would be adequately subserved if the impugned judgment is modified by vacating the injunction granted by the impugned judgment and requiring the appellant, instead, to file, with the Registry of this Court and an advance copy to the respondent, audited accounts of the amounts earned by the appellant by sale of the allegedly infringing product, till the expiry of the suit patent. As a period of hardly four months remains till the suit patent expires, this arrangement would, to our mind, protect the interests of both sides and would also ensure that the availability of the appellant’s product to the public, who may be in need of it, is not restrained any further.
28. The impugned judgment stands modified accordingly.
29. The appeal is allowed to the aforesaid extent with no orders as to costs.
This decision comes off the heels of an October 2025 ruling by the division bench on risdiplam. As reported in KEI’s blog,
“On 9 October 2025, the division bench of the Delhi High Court upheld a ruling allowing Indian company Natco to produce a generic version of risdiplam, rejecting Swiss drugmaker Roche’s patent infringement claim. The Court found credible grounds that Roche’s patent lacked novelty, reinforcing the Court’s earlier March 2025 decision. Legally, the ruling addressed Roche’s request for an injunction preventing Natco from making its generic version available in the India market.”
This January 2026 ruling by the division bench of the Delhi High Court on nivolumab is consequential as it reinforces the principle that the public interest is a determining factor when courts consider pleas for injunctive relief as they relate to life-saving medicines.